Global Update on the Cell & Gene Therapy Regulatory Landscape
The lengthening shadow of increase in health spending in the coming years is sharpening the minds of legislators, regulators and payers alike. The growing time-to-market, the rising costs in development of novel medicines, as well as the more basic drive to be ‘ahead of the game’, forces the industry and the legislators to rethink basic postulates of drug development. The global regulatory environment is undergoing major reshape, allowing patients early access to breakthrough technology and allowing industry opportunities for early access to market. Patient advocacy groups are incorporated in legislation discussions, and are brought into the room where industry and regulator discuss the clinical development of novel therapies. Earlier access to market allows smaller commercial companies to jump through the ‘death valley’ of drug development, reduce the traditional high investment risks in biotechnology, and ultimately provide more competition to big and well-established pharma giants.
Submitted for review: Apr 22nd 2018 Published: 17th July 2018
Citation: Cell Gene Therapy Insights 2018; 4(6), 555-561